Data / Medical devices / China / Shenzhen Sophway Technology Co., Ltd.
Shenzhen Sophway Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Sophway Technology Co., Ltd. is registered with the FDA (registration 3043152784) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043152784
- Address
- A1301A, Building 1, Meixun Digital Technology Factory, No. 19 Jinxiu Middle Road Laokeng Community, Longtian Street, Pingshan District, Shenzhen Guangdong, China, 518122
- Owner or operator
- Shenzhen Sophway Technology Co., Ltd. (10094859)
- Roles
- Manufacturer
- First device listed
- December 30, 2025
- Registered through
- 2026
- Brand names listed
- 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N), Endoscopic Camera System (SV-300, SV-300I, SV-300R, SV-300N), Endoscopic LED Light Source (SL-200, SL-200N)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2025 | K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | GCJ | Substantially Equivalent | Shenzhen Sophway Technology Co., Ltd. | accessdata.fda.gov |
| July 1, 2025 | K250204 | Endoscopic Camera System | FET | Substantially Equivalent | Shenzhen Sophway Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Led Light Source
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Updated October 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.